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Rule

Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Heska Corp. to Pharmacia & Upjohn Co.

DATES:

This rule is effective July 26, 2000.

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FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.

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SUPPLEMENTARY INFORMATION:

Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525, has informed FDA that it has transferred to Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199 ownership of, and all rights and interests in NADA 141-082. Accordingly, the agency is amending the regulations in 21 CFR 522.778 to reflect the transfer of ownership.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

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List of Subjects in 21 CFR Part 522

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 360b.

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[Amended]

2. Section 522.778 Doxycycline hyclate is amended in paragraph (b) by removing “063604” and adding in its place “000009”.

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Dated: July 18, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. 00-18825 Filed 7-25-00; 8:45 am]

BILLING CODE 4160-01-F